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CV.ANDALAS CELEBES NUSANTARA (ACN)

⚠️ Moderate Risk

FEI: 3015924176 • Kec Medan Johor • INDONESIA

FEI

FEI Number

3015924176

📍

Location

Kec Medan Johor

🇮🇩

Country

INDONESIA
🏢

Address

Lk V, Kel Kedaidurian No. 40-A, , Kec Medan Johor, , Indonesia

Moderate Risk

FDA Import Risk Assessment

27.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
5
Unique Violations
1/16/2020
Latest Refusal
1/16/2020
Earliest Refusal

Score Breakdown

Violation Severity
58.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

91×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

Refusal History

DateProductViolationsDivision
1/16/2020
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
218LIST INGRE
320LACKS FIRM
473LABELING
9SALMONELLA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CV.ANDALAS CELEBES NUSANTARA (ACN)'s FDA import refusal history?

CV.ANDALAS CELEBES NUSANTARA (ACN) (FEI: 3015924176) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2020 to 1/16/2020.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. CV.ANDALAS CELEBES NUSANTARA (ACN)'s FEI number is 3015924176.

What types of violations has CV.ANDALAS CELEBES NUSANTARA (ACN) received?

CV.ANDALAS CELEBES NUSANTARA (ACN) has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about CV.ANDALAS CELEBES NUSANTARA (ACN) come from?

All FDA import refusal data for CV.ANDALAS CELEBES NUSANTARA (ACN) is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.